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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tubes, gastrointestinal (and accessories)
510(k) Number K962554
Device Name FLEXIFLO LOW-PROFILE BALLOON GASTROSTOMY TUBE
Applicant
ABBOTT LABORATORIES
625 CLEVELAND AVE.
COLUMBUS,  OH  43215
Applicant Contact DANIEL HAMILTON
Correspondent
ABBOTT LABORATORIES
625 CLEVELAND AVE.
COLUMBUS,  OH  43215
Correspondent Contact DANIEL HAMILTON
Regulation Number876.5980
Classification Product Code
KNT  
Date Received07/01/1996
Decision Date 11/07/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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